Orthotic and prosthetic device and manufacturing system and method

ABSTRACT

A prosthetic device includes a socket, fasteners, and a pylon. The socket defines a cavity configured to receive a residual limb of a user. The socket includes a base defining multiple blind-holes. Each of the fasteners are configured to be received within a corresponding one of the blind-holes. The fasteners each include internal threads. The pylon includes through-holes that are aligned with a corresponding one of the blind-holes. The pylon is configured to be directly coupled with the base of the socket through externally threaded fasteners that extend through the through-holes and threadingly couple with the internal threads of the plurality of fasteners.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. application Ser. No.16/050,849, filed Jul. 31, 2018, which is a continuation ofInternational Application No. PCT/US2017/015981, filed Feb. 1, 2017,which claims priority to U.S. Provisional Patent Application No.62/290,254, filed on Feb. 2, 2016, all of which are incorporated hereinby reference in their entireties and for all purposes.

TECHNICAL FIELD

The present application relates to orthotic and prosthetic devices andmanufacturing systems and methods.

BACKGROUND

Three-dimensional printing and additive manufacturing (referred hereinas “3D printing”) has introduced many new manufacturing capabilities invarious industries. For example, through 3D printing, it is possible toefficiently create rapid prototypes or various layered designs noteasily feasible with conventional manufacturing. However, 3D printing istraditionally used with a limited range of materials, which may be weakand brittle. Additionally, 3D printing devices often are limited in thenumbers and types of materials that can be used to manufacture devices.

SUMMARY

Various example embodiments relate to a prosthetic device including asocket, a pylon, and a connection insert. In some embodiments, thesocket defines a cavity configured to receive a residual limb of a user.In some embodiments, the pylon is coupled to a distal end of the socketby a threaded fastener. In some embodiments, the connection insert iswithin the socket and is configured to receive the threaded fastener tocouple the pylon with the socket. In some embodiments, at least one of avacuum line or a wire passes from an exterior of the socket and throughan opening of the connection insert to provide fluid communicationbetween the exterior and the cavity.

In some embodiments, the socket is formed by a three-dimensionalprinting process. In some embodiments, the connection insert includes aninternally threaded fastener aligned with a through hole in the socket,wherein the internally threaded fastener is structured to receive thethreaded fastener thereby securing the pylon to the socket.

In some embodiments, the connection insert is made of metal. In someembodiments, the socket is made of three-dimensionally printed plastic.In some embodiments, the connection insert defines multiple internallythreaded fasteners disposed about the connection insert at corners of asquare pattern.

In some embodiments, the connection insert is X-shaped. In someembodiments, the connection insert is U-shaped.

Another embodiment relates to a prosthetic device including a socket, apylon, and a connection insert. In some embodiments, the socket definesa cavity configured to receive a residual limb of a user. In someembodiments, the pylon is coupled to a distal end of the socket by aplurality of threaded fasteners. In some embodiments, the connectioninsert within the socket includes multiple internally threaded fastenersconfigured to receive the plurality of threaded fasteners to couple thepylon with the socket. In some embodiments, the socket extends along anentirety of a top surface of the connection insert.

In some embodiments, the socket is formed by a three-dimensionalprinting process. In some embodiments, the connection insert includesmultiple arms and multiple outer rings. In some embodiments, each of themultiple internally threaded fasteners is positioned at one of the outerrings.

In some embodiments, each of the internally threaded fasteners arealigned with a corresponding through hole in the socket. In someembodiments, the internally threaded fasteners are structured to receivethe plurality of threaded fasteners thereby securing the pylon to thesocket.

In some embodiments, the threaded fasteners include a first internallythreaded fastener, a second internally threaded fastener, a thirdinternally threaded fastener, and a fourth internally threaded fastener

In some embodiments, each of the first, second, third, and fourthinternally threaded fasteners define a circular opening having a centerpoint. In some embodiments, the first, second, third, and fourthinternally threaded fasteners are positioned such that the four centerpoints define vertices of a square.

In some embodiments, the connection insert has an overall X-shape. Insome embodiments, the connection insert has an overall U-shape.

Another embodiment relates to a prosthetic device including a socket,multiple fasteners, and a pylon. In some embodiments, the socket definesa cavity configured to receive a residual limb of a user. In someembodiments, the socket includes a base defining multiple blind-holes.In some embodiments, each of the fasteners is configured to be receivedwithin a corresponding one of the multiple blind-holes. In someembodiments, the fasteners each include internal threads. In someembodiments, the pylon includes multiple through-holes. In someembodiments, each of the through-holes are aligned with a correspondingone of the blind-holes. In some embodiments, the pylon is configured tobe directly coupled with the base of the socket through externallythreaded fasteners extending through the through-holes and threadinglycoupling with the internal threads of the fasteners.

In some embodiments, the pylon is configured to directly contact anexterior surface of the bottom of the socket when the pylon is directlycoupled with the base of the socket. In some embodiments, the fastenerseach include the internal threads and external threads. In someembodiments, each of the fasteners are threaded into a corresponding oneof the blind-holes.

In some embodiments, the fasteners, the through-holes, the blind-holes,and the externally threaded fasteners include four fasteners, fourthrough-holes, four blind-holes, and four externally threaded fasteners.In some embodiments, the base further includes a center hole extendingthrough an entire thickness of the base. In some embodiments, the blindholes are radially disposed about the center hole.

These and other features, together with the organization and manner ofoperation thereof, will become apparent from the following detaileddescription when taken in conjunction with the accompanying drawings,wherein like elements have like numerals throughout the several drawingsdescribed below.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 shows a system for making a custom fit prosthetic or orthoticdevice according to an example embodiment.

FIG. 2 shows a cross-sectional exploded view of a prosthetic deviceaccording to an example embodiment.

FIG. 3A shows a top view of a connection insert for a prosthetic deviceaccording to an example embodiment.

FIG. 3B shows a cross-sectional view of the connection insert of FIG.3A.

FIG. 4A shows a top view of a connection insert for a prosthetic deviceaccording to another example embodiment.

FIG. 4B shows a cross-sectional view of the connection insert of FIG.4A.

FIG. 5 shows a flow diagram of a method of making an orthotic orprosthetic device according to an example embodiment.

FIG. 6 shows a flow diagram of a sub-method of the method of FIG. 5.

FIG. 7 shows a front view of another prosthetic device according to anexemplary embodiment.

FIG. 8 shows a side view of the prosthetic device of FIG. 7.

FIG. 9 shows a bottom view of the prosthetic device of FIG. 7 includingdifferent openings for receiving fasteners.

FIG. 10 shows a sectional view of a bottom portion of the prostheticdevice of FIG. 7.

DETAILED DESCRIPTION

Referring to the figures generally, systems and methods for creatingcustom-fit prosthetic devices, orthotic devices, and related medicaldevices via three-dimensional printing (3D printing) or additivemanufacturing techniques are described. For example, the describedsystems and methods may be used to fabricate prosthetic devices, cranialremolding orthosis devices, ankle-foot orthosis devices, upper and lowerextremity prosthetic devices, shoe inserts, and the like. Through thedescribed systems and methods, a residual limb or other body part of apatient is scanned and analyzed to determine measurements andcharacteristics of the residual limb. The measurements andcharacteristics of the residual limb are used to design a customizeddevice for the residual limb. The customized device uses multipledifferent materials. For example, the customized device may use a firstmaterial for a frame and a second material for a liner, wherein thefirst material is more rigid than the second material. The customizeddevice is fabricated using a three-dimensional printer that is capableof printing and bonding multiple different materials at the same time.

Referring to FIG. 1, a system 100 for making a custom fit prosthetic ororthotic device is shown according to an example embodiment. The system100 includes a 3D scanner 102, a manufacturing computing system 104, anda 3D printer 106. The 3D scanner 102 is structured to scan a residuallimb 108 of a patient. The residual limb 108 may be, for example, aportion of an arm of the patient, a portion of a leg of the patient, orthe like. The 3D scanner 102 includes a residual limb support 110. Theresidual limb support 110 secures the residual limb 108 of the patientin the 3D scanner 102 such that the motion of the residual limb 108 islimited during scanning. The residual limb 110 support is adjustable toaccommodate different sizes and different types of residual limbs. The3D scanner 102 includes at least one scanning device 112. The scanningdevice 112 may be a camera, an infrared camera, a laser, an ultrasonicsensor, a contact sensor, or the like. The scanning device 112 measuresthe geometry and size of at least a portion of the residual limb 108. Insome arrangements, the scanning device 112 maps the portion of theresidual limb 108 as a three-dimensional map. The three-dimensional mapmay be formed by a table of three-dimensional coordinates. In somearrangements, the scanning device 112 rotates about the residual limb108 to measure the entirety of the portion of the residual limb 108.

The manufacturing computing system 104 is communicatively coupled to the3D scanner 102 and the 3D printer 106. Generally, the manufacturingcomputing system 104 controls the operation of the 3D scanner 102 andthe 3D printer 106. In some arrangements, the manufacturing computingsystem 104 is integrated with at least one of the 3D scanner 102 or the3D printer 106. The manufacturing computing system 104 includes variouscircuits that control the operation of the manufacturing system 104,including a communication circuit 114, a scanning circuit 116, atemplate customization circuit 118, a printing circuit 120, and a userinterface circuit 122.

The communication circuit 114 is structured to facilitate datacommunication to and from other devices, such as the 3D scanner 102 andthe 3D printer 106. In some arrangements, data passing through thecommunication circuit 114 is encrypted. The data communication via thecommunication circuit 114 may be communicated directly between themanufacturing computing system 104 and other devices or via a network(e.g., the Internet). The communication circuit 114 may be structured tocommunicate via any combination of wired network protocols (e.g.,Ethernet, USB, Thunderbolt, etc.) and wireless network protocols (e.g.,WiFi, Bluetooth, CDMA, GSM, LTE, ZigBee, etc.).

The scanning circuit 116 is structured to control the operation of the3D scanner 102. For example, the scanning circuit 116 can instruct thescanning device 112 to analyze the residual limb 108 based on aninstruction received from a technician (e.g., via the user interfacecircuit 122). In doing so, the scanning circuit 116 may control themovement (e.g., rotation) of the scanning device 112 with respect to theresidual limb 108. In some arrangements, the scanning circuit 116transforms the information received from the scanning device 112 to athree-dimensional map file that is formed by a table ofthree-dimensional coordinates.

The template customization circuit 118 modifies a selected devicetemplate from the template database 124 based on the size and shape ofthe residual limb 108. The template database 124 stores design templatesfor various prosthetic and orthotic devices (e.g., prosthetic arms,prosthetic hands, prosthetic legs, orthotic inserts, etc.) that can beprinted by the 3D printer 106. The templates stored in the templatedatabase 124 may be organized by type (e.g., arm, leg, foot, etc.) andsize (e.g., by age, by height of the patient, by weight of the patient,etc.). In some arrangements, the template database 124 also storesadd-on or additional features that can be added to a given orthotic orprosthetic template, such as capacitive touch features, lining styles,vacuum assist features, openings for sensors, and the like. The templatecustomization circuit 118 is structured to allow a user to select atemplate of a device (e.g., via the user interface circuit 122) and tomodify the template to fit the residual limb 108 based on theinformation received from the 3D scanner 102. The modified template isthe design for the custom-fit orthotic or prosthetic device.

The manufacturing computing system 104 includes the printing circuit120. The printing circuit 120 is structured to generate and sendinstructions to the 3D printer 106 (e.g., via the communication circuit114). The printing circuit 120 generates the instructions from thedesign generated by the template customization circuit 118 by convertingthe design into tool path instructions (e.g., via computer-aidedmanufacturing (CAM) conversions) for the 3D printer 106. Theinstructions identify the print head path and the material needed toprint each section of the device.

The manufacturing computing system 104 includes the user interfacecircuit 122. The user interface circuit 122 is structured to allow auser to interact with the manufacturing computing system 104.Accordingly, the user interface circuit 122 may include user outputdevices (e.g., a display, speakers, LEDs, lights, etc.) and user inputdevices (e.g., a keyboard, a mouse, a touchscreen display, etc.).

Still referring to FIG. 1, the system 100 includes the 3D printer 106.The 3D printer 106 is structured to print the device as instructed bythe printing circuit 120 of the manufacturing computing system 104. Insome arrangements, the 3D printer 106 is a large format 3D printer witha print area large enough to accommodate any printed prosthetic ororthotic device. The 3D printer 106 includes multiple print heads,wherein each head can print a different one of the raw materials 128.The different print heads may include any combination ofstereolithography print heads, digital light processing print heads,fused deposition modeling print heads, selective laser sintering printheads, selective laser melting print heads, electronic beam meltingprint heads, and/or laminated object manufacturing print heads. The rawmaterials 128 may include any combination of Acrylonitrile ButadieneStyrene (ABS), Polylactic Acid (PLA), Nylon, polyethylene co-polymer,Thermoplastic elastomer (TPE), polypropylene, thermoplastic polyurethane(TPU), rubber-elastomeric polymer, etc. These materials can also beformulated with glass fiber, carbon nanotubes, carbon fiber, Poly VinylAlcohol (PVA), and the like.

Referring to FIG. 2, a cross-sectional exploded view of a prostheticdevice 200 is shown according to an example embodiment. The prostheticdevice 200 may be, for example, a prosthetic leg. The prosthetic device200 generally includes a socket 202 defining a cavity 204. The cavity204 is structured to receive a residual limb of the user. The socket 202is formed by the 3D printing process and materials described herein. Thesocket 202 includes a connection insert 206. The connection insert 206is embedded in the material forming the socket 202. The connectioninsert 206 is embedded at a distal end of the socket 202. The connectioninsert 206 is configured to allow external components to be removablyattached to the socket 202. Generally, the connection insert 206includes threaded openings configured to receive the threaded fasteners208. In its simplest form, the connection insert 206 includes a threadedfastener (e.g, a threaded nut, a threaded fastener coupled to a washer,etc.) that is embedded in the material forming the socket 202. Thestructure and arrangement of the connection insert 206 is described infurther detail below with respect to FIGS. 3 and 4. In somearrangements, the connection insert defines a plurality of apertures andone or more connector portions fixing the positions of the aperturesrelative to one another. In one arrangement, the connector portions areelongated connector portions. In further arrangements, the connectorportions define an “X,” “U” or other shape (e.g., a hollow square orcircle, etc.) that provides for significant gaps of material within aperiphery defined by the plurality of apertures. The socket 202 includesthrough-holes 210 aligned with the threaded openings of the connectioninsert 206 to allow the fasteners to pass through the body of the socket202 and engage the connection insert 206. The fasteners 208 are used tosecure a pylon 212 to the socket 202. The pylon 212 may carry, forexample, a prosthetic foot, a vacuum device, a controller, or the like.In an alternate arrangement, the socket 202 is divided into a firstportion having the embedded connection insert 206 (i.e., a distal end ofthe socket 202), and a second portion including the cavity 204. In suchan arrangement, the first portion may be injection molded and the secondportion may be 3D printed onto the first portion. The prosthetic device200 may have the same or similar arrangement and/or features as theprosthetic devices described in U.S. Pat. No. 9,486,334, which is hereinincorporated by reference in its entirety and for all purposes.

In non-3D printed sockets for prosthetic devices (e.g., such as thosedescribed in U.S. Pat. No. 9,486,334), the pylons are attached to thesocket via an external threaded adapter. The threaded adapter may be,for example, a solid disc-shaped connection insert having threaded holesto receive fasteners (e.g., similar to the fasteners 208 of thedescribed prosthetic device). The solid disc-shaped connection insert issecured to the distal end of the socket via epoxy, covering in carbonfiber, or the like. However, 3D printed sockets formed with methods andmaterials described herein generally do not possess the strength to havea connection insert secured to the outside of the socket 202. If adisc-shaped connection insert is secured to the outside distal end ofthe socket 202, the socket may crack or brake. Further, the embedding ofsuch a disc-shaped connection insert into the socket during the 3Dmanufacturing process causes the socket to crack and become unusableafter a brief usage period (e.g., less than 10,000 steps taken in theprosthetic device). The cracking and breaking of the socket due toembedding an existing connection insert (i.e., the solid cylindricaldisc connection insert) is often due in part to the connection insertnot allowing enough 3D printed material to intertwine with theconnection insert and in part to the shape of the connection insertconcentrating tensile and sheer stresses at specific locations of thesocket. However, these problems are addressed through unique designs ofthe embedded connection insert 206.

Referring to FIGS. 3A and 3B, views of a connection insert 300 are shownaccording to an example embodiment. FIG. 3A shows a top view of theconnection insert 300. FIG. 3B shows a close-up cross-sectional view ofthe connection insert 300 taken along section A-A of FIG. 3A. Theconnection insert 300 may be used as the connection insert 206 of theprosthetic device 200. The connection insert 300 has an overall X-shapewith four arms 302 extending from a central ring 304. The central ring304 defines a central opening 306. In some arrangements, each of thefour arms 302 are the same length. Although shown as including four arms302, any number of arms may be used in alternate arrangements. In suchalternate arrangements, the arms 302 are arranged in a symmetricalmanner (i.e., even circumferential spacing with respect to the centralring 304). Each of the arms 302 extends to an outer ring 308. As shownbest in FIG. 3B, the outer rings 308, arms 302, and central ring 304 maybe formed of a single material. For example, the outer rings 308, thearms 302, and the central ring 304 may be formed from a stamped sheet ofsteel, aluminum, or titanium.

The outer rings 308 define central openings that receive internallythreaded fasteners 310. The internally threaded fasteners 310 may besecured in the central openings of the outer rings 308 by press fit,welding, adhesive, riveting, or the like. In some arrangements, thecenter points of the circular openings of the internally threadedfasteners 310 define the vertices of a square 312 (e.g., as shown inFIG. 3A). The internally threaded fasteners 310 are configured toreceive the threaded fasteners 208 of the prosthetic device 200. In somearrangements, the internally threaded fasteners 310 are threadedaccording to the M6-1.0 threading standard. The circular shape of theouter rings 308 helps to evenly distribute the stresses (e.g., thetorque, the compression) from the fasteners 208 in an even manner intothe 3D printed material surrounding the outer rings 308.

The central opening 306 allows for wires or tubes to be passed throughthe connection insert 300. For example, in some arrangements, theprosthetic device is fitted with a vacuum system that helps retain aresidual limb in the cavity 204. In such arrangements, a vacuum tube maybe passed from a vacuum system external to the socket 202, through thecentral opening 306, and into the cavity 204. Similarly, sensor wires(e.g., vacuum sensor wires, pressure sensor wires, etc.) may be passedthrough the central opening 306. In some arrangements, the centralopening 306 is fitted with a vacuum port or a vacuum line. In sucharrangements, the socket 202 can include a 3D printed channel connectingthe vacuum port or vacuum line to the cavity 204 and/or to the exteriorof the socket 202 thereby eliminating the need to drill through thesocket 202.

The connection insert 300 may be aligned in a particular manner duringmanufacturing of the prosthetic device 200. In some arrangements, theconnection insert 300 is aligned such that a face of the square 312 isparallel to the ground when a user is wearing and standing with theprosthetic device 200. In such arrangements, the connection insert 300allows for the pylon 212 to be installed such that the axial length ofthe pylon 212 is substantially parallel to the direction of gravity whenthe user is wearing and standing with the prosthetic device 200. Infurther arrangements, the connection insert 300 is aligned such that oneof the gaps 314 between adjacent arms 302 is aligned with a front sideof the socket 202. The gaps 314 extend outward beyond the periphery ofthe square 312. The front side of the socket 200 is worn on the sameside of the residual limb as the user's knee. Accordingly, the frontside of the socket 200 faces forward during a forward-facing walk by theuser of the prosthetic device. The front side of the socket 202experiences the highest amount of tensile stress during use by the user.Aligning the connection insert 300 such that one of the gaps 314 facesforward maximizes the amount of 3D printed material in the direction ofthe user's forward walk, which increases the strength of the socket 200and reduces the risk of the socket 200 breaking in the area of theconnection insert 300.

In an alternate arrangement, the connection insert 300 does not includethe arms 302 or the central ring 304. In such an arrangement, theconnection insert 300 includes four threaded fasteners 310, each coupledto a respective outer ring 308 (e.g., a circular washer). Thealternative arrangement provides more flexibility in in terms ofplacement of the threaded fasteners within the socket 202.

The overall X-shape of the connection insert 300 reduces the amount ofmaterial occupied by the connection insert 300 itself compared to acylindrical disc having threaded holes (i.e., the externally attachedconnection insert described above). Accordingly, when the connectioninsert 300 is embedded in the socket 202 (e.g., as shown with respect tothe connection insert 206), more 3D printed material can be used in thesocket 202, which helps to evenly distribute the load of the user andthe pylon through a greater area of the socket 202. The X-shape of theconnection insert 300 achieves substantially better longevity anddurability of the socket 202 compared to a cylindrical disc shapedconnection inserts of prior prosthetic devices.

Referring to FIGS. 4A and 4B, views of a connection insert 400 are shownaccording to an example embodiment. FIG. 4A shows a top view of theconnection insert 400. FIG. 4B shows a close-up cross-sectional view ofthe connection insert 400 taken along section B-B of FIG. 4A. Theconnection insert 400 is similar to the connection insert 300. Theconnection insert 400 may be used as the connection insert 206 of theprosthetic device 200. The connection insert 400 has an overall U-shapewith three arms 402 extending between and serially connecting fourcircular sections 404. In another arrangement, the connection insert 400has an overall crescent shape. The circular sections 404 and the arms402 may be formed of a single material, such as a stamped sheet ofsteel, aluminum, or titanium. The overall U-shape defines a centralopening 406.

The circular sections 404 define central openings that receiveinternally threaded fasteners 408. The internally threaded fasteners 408may be secured in the central openings of the circular sections 404 bypress fit, welding, adhesive, riveting, or the like. In somearrangements, the center points of the circular openings of theinternally threaded fasteners 408 define the vertices of a square 410(e.g., as shown in FIG. 3A). The internally threaded fasteners 408 areconfigured to receive the threaded fasteners 208 of the prostheticdevice 200. In some arrangements, the internally threaded fasteners 408are threaded according to the M6-1.0 threading standard. The circularshape of the circular sections 404 helps to evenly distribute thestresses (e.g., the torque, the compression) from the fasteners 208 inan even manner into the 3D printed material surrounding the circularsections 404.

The central opening 406 allows for wires or tubes to be passed throughthe connection insert 400. For example, in some arrangements, theprosthetic device is fitted with a vacuum system that helps retain aresidual limb in the cavity 204. In such arrangements, a vacuum tube maybe passed from a vacuum system external to the socket 202, through thecentral opening 406, and into the cavity 204. Similarly, sensor wires(e.g., vacuum sensor wires, pressure sensor wires, etc.) may be passedthrough the central opening 406.

The overall U-shape of the connection insert 400 reduces the amount ofmaterial occupied by the connection insert 400 itself compared to acylindrical disc having threaded holes (i.e., the externally attachedconnection insert described above). Accordingly, when the connectioninsert 400 is embedded in the socket 202 (e.g., as shown with respect tothe connection insert 206), more 3D printed material can be used in thesocket 202 which helps to evenly distribute the load of the user and thepylon through a greater area of the socket 202. The U-shape of theconnection insert 400 achieves substantially better longevity anddurability of the socket 202 compared to a cylindrical disc shapedconnection inserts of prior prosthetic devices.

The connection insert 400 may be aligned in a particular manner duringmanufacturing of the prosthetic device 200. In some arrangements, theconnection insert 400 is aligned such that a face of the square 410 isparallel to the ground when a user is wearing and standing with theprosthetic device 200. In such arrangements, the connection insert 400allows for the pylon 212 to be installed such that the axial length ofthe pylon 212 is substantially parallel to the direction of gravity whenthe user is wearing and standing with the prosthetic device 200. Infurther arrangements, the connection insert 400 is aligned such thatopen end of the U-shape is aligned with a front side of the socket 202.The front side of the socket 200 is worn on the same side of theresidual limb as the user's knee. Accordingly, the front side of thesocket 200 faces forward during a forward-facing walk by the user of theprosthetic device. The front side of the socket 202 experiences thehighest amount of tensile stress during use by the user. Aligning theconnection insert 400 such that the open end of the U-shape facesforward maximizes the amount of 3D printed material in the direction ofthe user's forward walk, which increases the strength of the socket 200and reduces the risk of the socket 200 breaking in the area of theconnection insert 400.

Referring to FIG. 5, a method 500 of making an orthotic or prostheticdevice is shown according to an example embodiment. The method 500 isperformed by the components of the system 100. With the exception of thescanning (at 502) and the printing (at 516), the method 500 is performedby the manufacturing computing system 104. The output of the method 500may be, for example, the prosthetic device 200 or another orthotic orprosthetic device.

The method 500 begins when a residual limb is scanned at 502. Theresidual limb 108 is scanned by the 3D scanner 102. A technician securesthe residual limb 108 in the correct position in the 3D scanner 102. Insome arrangements, the residual limb 108 is secured in the residual limbsupport 110. After the residual limb 108 is secured in the correctposition within the 3D scanner 102, the manufacturing computing system104 sends a scan instruction to the 3D scanner 102 (e.g., via thescanning circuit 116). The scanning devices 112 of the 3D scanner 102measure the shape and dimensions of the residual limb 108. The scanningdevices 112 may include any of cameras, infrared cameras, lasers,ultrasonic sensors, contact sensors, or the like. In some arrangements,the scanning device 112 rotates about the residual limb 108 during 502to measure the entirety of the portion of the residual limb 108. The 3Dscanner 102 generates an output file based on the information from thescanning devices 112. In some arrangements, the output file is athree-dimensional map of the residual limb 108. The three-dimensionalmap may be formed by a table of three-dimensional coordinates includedin the output file.

The residual limb scan information is received at 504. The manufacturingcomputing system 104 receives the residual limb scan information fromthe 3D scanner 102. In some arrangements, the scan information is storedin the output file. In such arrangements, the output file may include athree-dimensional map of the residual limb 108 and/or by a table ofthree-dimensional coordinates. The residual limb scan information isstored at the manufacturing computing system 104 for later use inmodifying a device template (e.g., as described in further detail belowwith respect to 510).

A device template selection is received at 506. The device templateselection is received by the manufacturing computing system 104 from auser (e.g., a prosthetic design technician) via the user interfacecircuit 122. The device template corresponds to a prosthetic device, anorthotic device, or another device. The device template is selected fromthe template database 124.

Optionally, device features or add-on selections are received at 508.The device feature and add-on selections (if any are made) are receivedby the manufacturing computing system 104 from the user via the userinterface circuit 122. The features and add-on selections includecustomizations to basic devices. For example, in arrangements where thedevice is a prosthetic arm with fingers, the features and add-ons mayinclude vacuum hold features, such as embedded vacuum conduits withinthe structure of the device, or capacitive touch fingertips made out ofa different material than the standard fingertips of the devicetemplate. As another example, if the device is a prosthetic leg (e.g.,the prosthetic device 200), the add-ons may include embedded supportbrackets (e.g., the connection inserts 206, 300, 400, etc.), internalvacuum conduits, sensor mounts, sensor wire conduits, pylon connectingholes, and the like. Other example features and add-on selections mayinclude zippers; slots or apertures to allow for donning, doffing, andadjustment; mounting bosses; supports for tensioning devices such asstraps; lacing eyelets; printed interlocking surfaces (e.g., knob andpost, Velcro, etc.); and the like.

The selected device template is modified to form a final device designat 510. The manufacturing computing system 104 modifies the devicetemplate based on the shape and dimensions of the residual limb 108. Inarrangements where at least one device feature or add-on selection isreceived at 508, the manufacturing computing system 104 further modifiesthe device template based on the selected features or add-ons. Themanufacturing computing system 104 performs the template modificationvia the template customization circuit 118. In some arrangements, theuser oversees the automated modification of the device template andapproves the modified device template prior to certifying the modifieddevice template as the final device design. In an alternate arrangement,steps 506 through 510 are skipped and a technician designs the devicefrom scratch on the manufacturing computing system 104 based on theresidual limb scan information. A technician (e.g., a prosthetic designtechnician) may use a computer aided design (CAD) software installed onthe manufacturing computing system 104. The technician can interact withthe CAD software via the user interface circuit 122 to create the finaldevice design.

CAM instructions based on the final device design are generated at 512.The manufacturing computing system 104 converts the final device designinto CAM instructions that are readable by the 3D printer 106. Themanufacturing computing system 104 generates a file containing the CAMinstructions via the printing circuit 150. The CAM instructions includeprinting parameters for the 3D printer 106. The printing parametersinclude, for example, print head printing path, printing materials,printing temperatures, and the like. In some arrangements, the CAMinstructions include a break in the 3D printing of the device to allow atechnician to add a component to be embedded in the printed device(e.g., to add the connection insert 206 to the socket 202 duringprinting). The CAM instructions are transmitted to the 3D printer at514. The manufacturing computing system 104 transmits the file includingthe CAM instructions to the 3D printer 106.

The device is printed based on the CAM instructions at 516. The 3Dprinter 106 prints the device based on the CAM instructions. In doingso, the 3D printer 106 uses the raw materials 128 to make the device.The 3D printer can utilize multiple different materials in manufacturingthe same device such that the materials can be joined without the use ofadhesives or fasteners. For example, a prosthetic device can be printedthat has multiple materials, including a rigid material that forms aframe section of the prosthetic device and a soft padded foam area thatrests against the residual limb 108.

Referring to FIG. 6, a flow diagram of a detailed description of step516 of the method 500 is shown for printing the socket 202 of theprosthetic device 200. The 3D printer 106 begins printing the socket 202from the distal end at 602. The distal end of the socket 202 is the endof the socket 202 that connects to the pylon 212. In some arrangements,the 3D printer prints around the through-holes 210. In otherarrangements, the through-holes 210 are formed after the printingprocess (e.g., by drilling through the socket 202). The 3D printer 106forms a recess to receive the connection insert (e.g., the connectioninsert 206, 300, or 400) at 604. The recess includes at least onechannel or depression in the socket 202 that receives the connectioninsert.

After the socket is formed at 604, the printing operation is paused at606. The printing operation is paused when the socket is stillaccessible by a technician (e.g., before the socket is printed over withmaterial by the 3D printer 106). The connection insert is installed at608. A technician installs the connection insert into the socket 202.After the connection insert is installed, the printing operation isresumed at 610. The 3D printer 106 continues to print the socket 202,including laying material over and around the connection insert therebysecuring and embedding the connection insert in the socket 202. Thesocket is finished at 612. The 3D printer 106 continues printing thesocket until the socket 202 is finished.

In an alternative arrangement of the step 516 of the method 500, therecess formed at 604 extends to an exterior surface of the socket 202and forms a “key” slot. In such an arrangement, the connection insertcan be inserted into the socket 202 after the printing operation hasconcluded through the exposed key slot. Accordingly, in the alternativearrangement, the pausing of the printing operation 606 is skipped, andthe connection insert is installed after 612 (i.e., after the socket hasfinished printing). In some arrangements, the remaining empty spaceformed by the slot after inserting the connection insert is insertedinto the slot is filled with a filler material (e.g., epoxy, etc.).

The above-described 3D printing and additive manufacturing system andprocess allow for prosthetic devices and orthotic devices having uniqueintegral features. For example, devices can be printed that have slotsor apertures to allow for donning, doffing, and adjustment (e.g.,printed zippers, printed mounting bosses, printed supports fortensioning devices and straps). The printing operations can be paused(e.g., in a similar manner as described above with respect to installingthe connection insert) to add separate metal components, such as rods ortriangle style strap hinges directly into printed mounts or bosses onthe surface of a printed part. In further arrangements, parts can beprinted with eyelets positioned horizontally or vertically withreference to the surface for lacing and/or with reel lacing connections.Devices can be printed having integral mounting or adjustment straps ofthe same or different material as the device. The straps can be printedwith belt type holes and fasteners or with stepped or ratchetconnections. Strap management features (e.g., strap containment devices)can also be printed directly into the device.

3D printed devices can be printed to include mating surface interlockson selective areas instead of Velcro or belt tensioners that areconducive to 3D type printing. For example, knob and post connectors canbe printed. In this arrangement, a post is printed perpendicular to thesurface that has a sphere, or most of a sphere, printed on the top ofthe post. This would resemble a knob. These are printed in arrays on thesurfaces to be joined. The spheres of one surface would snap into agroup of four spheres on the other surface. Many of these connectionswould be made to provide the strength or strap management required. Thepost may be 0.1 inches tall and have a thickness of approximately 0.050inches, while the sphere can be 0.1 inches in diameter and rest on topof the post. The printed array can have the posts spaced at 0.150 incheson its x and y axis. This would allow a knob from a parallel surface toenter a group of four knobs and distort them slightly or compress theirknobs, so the intruding knob goes between and below the group of four.The pressure required to insert and release would be determined bymaterial durometer, material surface, sticky or slippery surface, sizeof knobs, spacing of the knobs, and shape of the knobs (e.g., knobshaving a shape other than spheres). For example, hemispheres for theknobs would allow the radius surfaces of the hemisphere to allow easierinsertion then the flats of the bottoms of the hemispheres to be againsteach other and provide more effort to release than insert. Other matingsurfaces can include dovetails, tapered bosses, pegs, or other printedmechanical interlocking features, to join multiple materials, or joinmultiple materials that are incompatible chemically, and would otherwisedelaminate. The use of the mating surfaces can be used to prevent two ormore materials from separating during dynamic operation of the device,to provide anti-torqueing or anti-rotation between the multiplematerials printed within the device, to allow for structural attachmentcomponents to connect the body of the printed device to other componentssuch as pyramid or pylon adapters, or wrist to hand connectors.

The 3D printing allows for varied use of the same material and the useof multiple materials that form an integral device. For example, 3Dprinting allows for the placement of two or more materials on the samelayer throughout the device during the same print cycle. For example,materials of different hardness can be printed in the same cycle (e.g.,where the padded foam area is ultimately placed against patient's skin),stiffening materials can be embedded to provide extra rigidity andrestrict movement, weight saving materials can be used where appropriate(e.g., the use of different infills), and the like. This may be used,for example, to print a prosthetic hand connection device that has acompliant or flexible area printed inline through the wrist to a rigidarea proximal to the wrist which is rigid for connection to the patient.The various portions can be printed during the same print cycle, whichallows flexion and extension along with pronation and supination. Asanother example, terrain compliance on devices can be added (e.g., thesole of an artificial foot can consist of variable thickness andvariable durometer materials, all printed during the same print cycle).As a further example, parts can be printed using two different materialshaving two different durometers, such as a first material that is harderand more rigid than a second material (e.g., an elastomer material), toprovide for areas of devices that can rotate, twist, or flex, which mayprovide a more comfortable fit to a user of the prosthetic or orthoticdevice. The use of different materials also allows for the printing ofsprings with 3D printed material (e.g., plastic coil or leaf springs forcompression or expansion applications between items that need to beseparated with a spring connection, articulations or “living hinges”within the device without separating the device in to multiplecomponents or adding additional external hardware, and the like).

The use of the above-described 3D printing systems and methods can alsoprovide for devices with integral voids in the material (e.g., formedwithout removing materials). For example, devices can be printed withintegral holes, slots, cutouts, embosses, debosses, or other blindrecesses (areas that do not go completely through the device), otheritems for secondary and external component attachment, void areas (e.g.,to reduce weight or allow ventilation openings), non-solid infills thatare offset to allow a cushioning effect until a certain parameter, suchas force, is achieved then allow a further movement by collapsing orotherwise compressing, and the like.

Similarly, the 3D printed infill ratio of a device can be varied atdifferent portions of the device. For example, a first portion of thedevice can utilize a 25% infill to provide weight savings, whereas asecond portion of the device can utilize a 100% infill to providegreater strength. The use of a higher infill (e.g., 100% infill insteadof 25% infill) allows for better modification of the device afterprinting. For example, a clinician can use heat to modify a portion of adevice printed with 100% infill (e.g., to the heated portion) to, forexample, create a brim on the edge of a socket. Whereas the reshapingvia heat is more difficult for areas with 25% infill because there isless material to modify and the risk of damaging the device isincreased.

Further, the use of the above-described systems and methods allows forunique electronic features to be integrated directly into the 3D printeddevices. For example, devices can be printed with electricallyconductive materials along with electrically isolated materials tocreate devices that contain printed wires, traces, or other electricallyconductive areas, that are on the surface or embedded within the device(e.g., to communicate patient signals, provide power to motors, providepower to cooling devices, provide patient neuro-stimulation, function asbattery or power supply connections, etc.). As another example, devicescan be printed with electrically conductive materials on the surface orembedded in the interior surfaces to provide Radio FrequencyInterference (RFI) shielding of electronic devices such as sensors,amplifiers or other components that require interference shielding, toallow for interaction with capacitive touch screen devices (e.g.,smartphones, tablets, ATMs, etc.) by printing the conductive surfaces onfingertips of a prosthetic hand.

Other features enabled by the above-described systems and methodsinclude the integral waterproofing of portions of the devices throughthe use of different materials, the integration of covers to protectcomponents, the printing of channels or tubes within the devices, andthe like.

Although the example device described in detail herein relates to aprosthetic limb, other improved prosthetic and orthotic devices can bemanufactured by the systems and methods described herein. For example,the same principles can be applied to the design and manufacture ofcranial remolding orthosis (CRO) devices. Currently, CRO devices arefabricated manually. For example, current CRO devices may bemanufactured by manually carving a foam block to form a model of apatient, coating the foam block with plastic, and manual trimming of theplastic. The existing manner of creating a CRO device is labor intensiveand time consuming. Through the manufacturing systems and methodsdescribed herein, the process is simplified and the device is improved.The technician can leverage the 3D scanner 102 and the manufacturingcomputing system 104 to create an accurate 3D CAD model of the CROdevice for a given patient. Any trimming of materials (e.g., for abetter fit, to add ventilation holes), modification of materialthickness can be performed on the CAD model instead of the actualdevice, thereby reducing time and risk of damage to the device. Once theCAD model is finalized, the 3D printer 106 can be configured to printthe CRO device. The 3D printer 106 can print multiple and connectedmaterials at the same time (e.g., the rigid outer frame of the CROdevice and the padded inner foam), thereby reducing assembly time forthe technician. Similar processes to the above-described one withrespect to the CRO device can be directly applied to other devices,including: ankle foot orthosis (AFO), trans-metatarsal orthosis (TMO),foot orthotics (FO), diabetic inserts, and body jackets utilized forspine correction, such as for patients with scoliosis, and the like.

In another arrangement, the above-described systems and methods can beused to create upper extremity prosthetic devices, such as prostheticarms. In such arrangements, the described connection inserts can beembedded in 3D printed sockets that receive residual arms in the samemanner described above. The connection inserts can be structured toreceive devices other than a pylon, such as a prosthetic hand, and caninclude openings to receive sensor wires that allow the users to controlthe operation of various motors and actuators in the attached prosthetichand.

The above-described systems and methods allow for prosthetic andorthotic devices to be manufactured as a single piece with integratedfeatures. For example, the devices may include rigid materials (e.g.,hard plastics or metals) and less rigid materials (e.g., soft foams andrubbers). Additionally, the devices may include integrated vacuumchannels within the frame, integrated closure mechanisms (e.g., 3Dprinted zippers, 3D printed knob and post attachments, integrated laceeyelets, 3D printed snaps, 3D printed dovetailing or mechanicalinterlocks, etc.), capacitive touch materials that connect the residuallimb 108 to an exterior of the prosthetic device (e.g., to a fingertip),3D printed living hinges, integrated radio frequency interferenceshielding that protects electronic devices of the prosthetic device,integrated water proofing components. Additionally, the above-describedsystems and methods reduce manufacturing times and costs for prostheticand orthotic devices.

Referring particularly to FIGS. 7-10, a prosthetic device 700 that canbe formed using any of the 3D printing techniques described herein isshown according to one embodiment. The prosthetic device 700 isconfigured to receive a lower residual limb at a first end 704 (e.g., aproximate end) and can be configured to couple to any other structuralelements (e.g., a pylon, a connection plate to indirectly couple theprosthetic device 700 with a pylon, etc.) at a second end 706 (e.g., adistal end). In some embodiments, the prosthetic device 700 has anoverall height 708 that is measured from a bottom periphery to a topperiphery of the prosthetic device 700. The overall height 708 can besubstantially equal to 268 millimeters, less than 200 millimeters,greater than 300 millimeters, etc. In some embodiments, the overallheight 708 is adjustable or custom for a user of the prosthetic device700 and may be formed for a custom-fit during the manufacturing processthat uses the 3D printing techniques.

The prosthetic device 700 includes a shell, socket, or sidewall 702having a shape corresponding to a shape of the residual limb. Thesidewall 702 includes an inner surface 716 and an outer surface 714. Theinner surface 716 and the outer surface 714 define a thickness of thesidewall 702. The thickness of the sidewall 702 may be uniform or mayvary spatially at different positions. For example, areas of thesidewall 702 that are anticipated or expected to undergo higher stressmay have an increased thickness relative to other areas that areexpected to undergo lower stress during use of the prosthetic device700. In some embodiments, different areas of the sidewall 702 thatshould deform to a shape of the user's residual limb have a decreasedthickness to facilitate controlled flexing or bending of the sidewall702 to facilitate comfort and proper fit of the prosthetic device 700.In some embodiments, the thickness of the sidewall 702 increases fromtop to bottom so that the thickness of the sidewall 702 proximate thebase 720 is greater than thickness of the sidewall 702 at the first end704. In some embodiments, variation of the thickness of the sidewall 702is configured based on patient activity level, weight, etc.

The sidewall 702 also defines an inner volume or an interior 718 intowhich the residual limb is received by the sidewall 702 (e.g., such thatthe residual limb abuts one or more portions or areas of the innersurface 716). The first end 704 defines an opening to facilitate accessto the interior 718 of the sidewall 702. During use, the user may inserttheir residual limb through the opening at the first end 704 of thesidewall 702 so that the residual limb is received within the interior718 of the prosthetic device 700.

The sidewall 702 also includes a bottom 720 at the second end 706. Thebottom 720 can include an aperture 710 (e.g., a bore, a hole, athrough-hole, an opening, a window, etc.) for receiving a fastener. Thebottom 720 also includes multiple apertures 712 configured to receivefasteners 722. The apertures 712 can be blind-holes that extend aparticular depth into the bottom 720 and are accessible from an exteriorof the bottom portion 706.

The bottom 720 can have a circular shape as shown in FIG. 9. Theapertures 712 are radially spaced from the aperture 710, which may bepositioned at a centerpoint of the bottom 720. In some embodiments, theapertures 712 include four apertures, each of which are angularly offset90 degrees from each other. For example, the apertures 712 can bepositioned at four corners of a square on the bottom 720. In someembodiments, the bottom 720 includes less than four apertures 712. Forexample, the bottom 720 may include three apertures 712 that areangularly offset from each other by 120 degrees in some embodiments. Inother embodiments, the bottom 710 includes more than four apertures 712(e.g., 5, 6, etc.) that are evenly angularly spaced relative to eachother.

Referring particularly to FIG. 10, the apertures 712 are each configuredto receive a corresponding one of the fasteners 722. In someembodiments, the fasteners 722 include external threads 724 and internalthreads 726. The external threads 724 may be self-tapping threads thatare configured to thread into a corresponding interior surface of one ofthe apertures 712. The internal threads 726 can be configured to receivea fastener for coupling the bottom 720 of the prosthetic device 700 to apylon or to indirectly couple the bottom 720 of the prosthetic device700 with a pylon. In some embodiments, the apertures 712 beingconfigured to receive the fasteners 722 facilitates coupling theprosthetic device 700 with a pylon without requiring a connection insert(e.g., the connection insert 400, the connection insert 300, theconnection insert 206). In this way, the fasteners 722 can be directlycoupled with the threaded fasteners 208 to couple the pylon 212 directlywith the sidewall 702 without requiring a connection insert. In otherembodiments, a connection insert similar to any of the connectioninserts disclosed herein may be utilized, and the fasteners 722 can becoupled to or separate from the connection insert.

As shown in FIG. 10, the pylon 212 may include multiple through holes214, each of the through holes 214 aligned with a corresponding one ofthe apertures 712 and/or the fasteners 722. The pylon 212 can bedirectly coupled with the sidewall 702 of the prosthetic device 700 byengagement between the fasteners 208 (e.g., threads thereof) and theinternal threads 726 of the fasteners 722. Particularly, the fasteners208 extend through the through holes 214 and engage the internal threads726 of the fasteners 722 which are threaded into the apertures 712,thereby fastening the pylon 212 with the base 720 of the sidewall 702.When the pylon 212 is coupled with the base 720 of the sidewall 702, asurface or upper periphery of the pylon 212 may directly abut, contact,engage, etc., a bottom or exterior surface or face of the base 720 ofthe sidewall 702.

The fasteners 208 and the fasteners 722 can be positioned in a circularpattern similarly to the apertures 712 as shown in FIG. 9. In someembodiments, the fasteners 208 and the fasteners 722 are positionedalong the circular pattern that is generally centered on the base 720.It should be understood that while FIG. 9 shows four apertures 712equally spaced in a circular pattern on the base 720, any number ofapertures 712 (e.g., 3, 5, etc.) may be provided on the base 720. Insome embodiments, the apertures 712 are equally spaced along thecircular pattern. In some embodiments, the apertures 712 are non-equallyspaced in a circular pattern about the base 720 in order to accommodatea particular user or area of the sidewall 702 that may experienceincreased forces or stress. The fasteners 208 and the fasteners 722 canbe disposed about the base 720 and the pylon 212 similarly to theapertures 712. In some embodiments, the through holes 214 are disposedabout the pylon 212 similarly to the apertures 712 so that the throughholes 214 align with the apertures 712 when assembled.

In some embodiments, the fasteners 722 (e.g., inserts) are manufacturedfrom a metal material so that the fasteners 722 thread into the sidewall702 (e.g., at an inner surface as the fasteners 722 are inserted orthreaded into the apertures 712). In some embodiments, the fasteners 722are manufactured from a material that has a hardness greater than ahardness of the material of the sidewall 702. In some embodiments, thefasteners 722 are manufactured from a material that is the same as orsimilar to the material of the sidewall 702. For example, the fasteners722 can be manufactured from any combination of Acrylonitrile ButadieneStyrene (ABS), Polylactic Acid (PLA), Nylon, polyethylene co-polymer,Thermoplastic elastomer (TPE), polypropylene, thermoplastic polyurethane(TPU), rubber-elastomeric polymer, etc. These materials can also beformulated with glass fiber, carbon nanotubes, carbon fiber, Poly VinylAlcohol (PVA), and the like. In some embodiments, the fasteners 722 are3D printed elements.

In some embodiments, the sidewall 702 or the base 720 are 3D printedaround the fasteners 722. For example, the fasteners 722 can be providedon a printing tray at desired locations, and the materials of thesidewall 702 can be dispensed over and around the fasteners 722 to buildup different layers of material of the sidewall 702. In someembodiments, the fasteners 722 are inserted or threaded into the base720 after the sidewall 702 has been printed. For example, the sidewall702 can be printed with the apertures 712 formed so that the fasteners722 can be inserted or threaded into the apertures 712 after completedprinting of the sidewall 702. In some embodiments, the fasteners 722 areflush with a bottom surface of the base 720. In some embodiments, thefasteners 722 are sub-flush with the bottom surface of the base 720. Forexample, the 3D printed material of the sidewall 702 can be printed sothat at least portion of a bottom surface of the fasteners 722 iscovered with the material so that only a threaded hole (e.g., internalthreads 726) are visible from a bottom of the base 720.

In some embodiments, the apertures 712 define an inner volume into whichthe fasteners 722 are inserted. In some embodiments, an inner sidewallof the apertures 712 includes printed threads into which the fasteners722 are inserted. The fasteners 722 can be threaded inserts that includea locking rotation feature. In some embodiments, the external threads724 are locking features (e.g., thin stakes) that are configured to biteor embed into an interior of the apertures 712 when inserted. In someembodiments, the fasteners 722 are permanently installed in the base720. In some embodiments, the fasteners 722 facilitate repeated removaland reinstallation of the threaded fasteners 208. In some embodiments,the fasteners 722 include key inserts for fixedly coupling within theapertures 712.

It should be noted that any use of the term “example” herein to describevarious embodiments is intended to indicate that such embodiments arepossible examples, representations, and/or illustrations of possibleembodiments (and such term is not intended to connote that suchembodiments are necessarily extraordinary or superlative examples).

The terms “coupled” and the like as used herein mean the joining of twomembers directly or indirectly to one another. Such joining may bestationary (e.g., permanent) or moveable (e.g., removable orreleasable). Such joining may be achieved with the two members or thetwo members and any additional intermediate members being integrallyformed as a single unitary body with one another or with the two membersor the two members and any additional intermediate members beingattached to one another.

It should be understood that no claim element herein is to be construedunder the provisions of 35 U.S.C. § 112(f), unless the element isexpressly recited using the phrase “means for.”

As used herein, the term “circuit” may include hardware structured toexecute the functions described herein. In some embodiments, eachrespective “circuit” may include machine-readable media for configuringthe hardware to execute the functions described herein. The circuit maybe embodied as one or more circuitry components including, but notlimited to, processing circuitry, network interfaces, peripheraldevices, input devices, output devices, sensors, etc. In someembodiments, a circuit may take the form of one or more analog circuits,electronic circuits (e.g., integrated circuits (IC), discrete circuits,system on a chip (SOCs) circuits, etc.), telecommunication circuits,hybrid circuits, and any other type of “circuit.” In this regard, the“circuit” may include any type of component for accomplishing orfacilitating achievement of the operations described herein. Forexample, a circuit as described herein may include one or moretransistors, logic gates (e.g., NAND, AND, NOR, OR, XOR, NOT, XNOR,etc.), resistors, multiplexers, registers, capacitors, inductors,diodes, wiring, and so on).

The “circuit” may also include one or more processors communicativelycoupled to one or more memory or memory devices. In this regard, the oneor more processors may execute instructions stored in the memory or mayexecute instructions otherwise accessible to the one or more processors.In some embodiments, the one or more processors may be embodied invarious ways. The one or more processors may be constructed in a mannersufficient to perform at least the operations described herein. In someembodiments, the one or more processors may be shared by multiplecircuits (e.g., circuit A and circuit B may comprise or otherwise sharethe same processor which, in some example embodiments, may executeinstructions stored, or otherwise accessed, via different areas ofmemory). Alternatively or additionally, the one or more processors maybe structured to perform or otherwise execute certain operationsindependent of one or more co-processors. In other example embodiments,two or more processors may be coupled via a bus to enable independent,parallel, pipelined, or multi-threaded instruction execution. Eachprocessor may be implemented as one or more general-purpose processors,application specific integrated circuits (ASICs), field programmablegate arrays (FPGAs), digital signal processors (DSPs), or other suitableelectronic data processing components structured to execute instructionsprovided by memory. The one or more processors may take the form of asingle core processor, multi-core processor (e.g., a dual coreprocessor, triple core processor, quad core processor, etc.),microprocessor, etc. In some embodiments, the one or more processors maybe external to the apparatus, for example the one or more processors maybe a remote processor (e.g., a cloud based processor). Alternatively oradditionally, the one or more processors may be internal and/or local tothe apparatus. In this regard, a given circuit or components thereof maybe disposed locally (e.g., as part of a local server, a local computingsystem, etc.) or remotely (e.g., as part of a remote server such as acloud based server). To that end, a “circuit” as described herein mayinclude components that are distributed across one or more locations.

An exemplary system for implementing the overall system or portions ofthe embodiments might include a general purpose computing computers inthe form of computers, including a processing unit, a system memory, anda system bus that couples various system components including the systemmemory to the processing unit. Each memory device may includenon-transient volatile storage media, non-volatile storage media,non-transitory storage media (e.g., one or more volatile and/ornon-volatile memories), etc. In some embodiments, the non-volatile mediamay take the form of ROM, flash memory (e.g., flash memory such as NAND,3D NAND, NOR, 3D NOR, etc.), EEPROM, MRAM, magnetic storage, hard discs,optical discs, etc. In other embodiments, the volatile storage media maytake the form of RAM, TRAM, ZRAM, etc. Combinations of the above arealso included within the scope of machine-readable media. In thisregard, machine-executable instructions comprise, for example,instructions and data which cause a general purpose computer, specialpurpose computer, or special purpose processing machines to perform acertain function or group of functions. Each respective memory devicemay be operable to maintain or otherwise store information relating tothe operations performed by one or more associated circuits, includingprocessor instructions and related data (e.g., database components,object code components, script components, etc.), in accordance with theexample embodiments described herein.

It should also be noted that the term “input devices,” as describedherein, may include any type of input device including, but not limitedto, a keyboard, a keypad, a mouse, joystick or other input devicesperforming a similar function. Comparatively, the term “output device,”as described herein, may include any type of output device including,but not limited to, a computer monitor, printer, facsimile machine, orother output devices performing a similar function.

The embodiments described herein have been described with reference todrawings. The drawings illustrate certain details of specificembodiments that implement the systems, methods and programs describedherein. However, describing the embodiments with drawings should not beconstrued as imposing on the disclosure any limitations that may bepresent in the drawings.

It should be noted that although the drawings herein may show a specificorder and composition of method steps, it is understood that the orderof these steps may differ from what is depicted. For example, two ormore steps may be performed concurrently or with partial concurrence.Also, some method steps that are performed as discrete steps may becombined, steps being performed as a combined step may be separated intodiscrete steps, the sequence of certain processes may be reversed orotherwise varied, and the nature or number of discrete processes may bealtered or varied. The order or sequence of any element or apparatus maybe varied or substituted according to alternative embodiments.Accordingly, all such modifications are intended to be included withinthe scope of the present disclosure as defined in the appended claims.Such variations will depend on the machine-readable media and hardwaresystems chosen and on designer choice. It is understood that all suchvariations are within the scope of the disclosure. Likewise, softwareand web implementations of the present disclosure could be accomplishedwith standard programming techniques with rule based logic and otherlogic to accomplish the various database searching steps, correlationsteps, comparison steps and decision steps.

It is important to note that the construction and arrangement of thevarious example embodiments are illustrative only. Although only a fewembodiments have been described in detail in this disclosure, thoseskilled in the art who review this disclosure will readily appreciatethat many modifications are possible (e.g., variations in sizes,dimensions, structures, shapes and proportions of the various elements,values of parameters, mounting arrangements, use of materials, colors,orientations, etc.) without materially departing from the novelteachings and advantages of the subject matter described herein. Forexample, elements shown as integrally formed may be constructed ofmultiple parts or elements, the position of elements may be reversed orotherwise varied, and the nature or number of discrete elements orpositions may be altered or varied. Additionally, features fromparticular embodiments may be combined with features from otherembodiments as would be understood by one of ordinary skill in the art.Other substitutions, modifications, changes and omissions may also bemade in the design, operating conditions and arrangement of the variousexample embodiments without departing from the scope of the presentdisclosure.

The foregoing description of embodiments has been presented for purposesof illustration and description. It is not intended to be exhaustive orto limit the disclosure to the precise form disclosed, and modificationsand variations are possible in light of the above teachings or may beacquired from this disclosure. The embodiments were chosen and describedin order to explain the principals of the disclosure and its practicalapplication to enable one skilled in the art to utilize the variousembodiments and with various modifications as are suited to theparticular use contemplated. Other substitutions, modifications, changesand omissions may be made in the design, operating conditions andarrangement of the embodiments without departing from the scope of thepresent disclosure as expressed in the appended claims.

What is claimed is:
 1. A prosthetic device comprising: a socket defininga cavity configured to receive a residual limb of a user; a pyloncoupled to a distal end of the socket by a threaded fastener; and aconnection insert within the socket configured to receive the threadedfastener to couple the pylon with the socket; wherein at least one of avacuum line or a wire passes from an exterior of the socket and throughan opening of the connection insert to provide fluid communicationbetween the exterior and the cavity.
 2. The prosthetic device of claim1, wherein the socket is formed by a three-dimensional printing process.3. The prosthetic device of claim 1, wherein the connection insertcomprises an internally threaded fastener aligned with a through hole inthe socket, wherein the internally threaded fastener is structured toreceive the threaded fastener thereby securing the pylon to the socket.4. The prosthetic device of claim 1, wherein the connection insert ismade of metal, and wherein the socket is made of three-dimensionallyprinted plastic.
 5. The prosthetic device of claim 1, wherein theconnection insert defines a plurality of internally threaded fastenersdisposed about the connection insert at corners of a square pattern. 6.The prosthetic device of claim 1, wherein the connection insert isX-shaped.
 7. The prosthetic device of claim 1, wherein the connectioninsert is U-shaped.
 8. A prosthetic device comprising: a socket defininga cavity configured to receive a residual limb of a user; a pyloncoupled to a distal end of the socket by a plurality of threadedfasteners; and a connection insert within the socket comprising aplurality of internally threaded fasteners configured to receive theplurality of threaded fasteners to couple the pylon with the socket;wherein the socket extends along an entirety of a top surface of theconnection insert.
 9. The prosthetic device of claim 8, wherein thesocket is formed by a three-dimensional printing process.
 10. Theprosthetic device of claim 8, wherein the connection insert comprises aplurality of arms and a plurality of outer rings, wherein each of theplurality of internally threaded fasteners is positioned at one of theouter rings.
 11. The prosthetic device of claim 8, wherein each of theinternally threaded fasteners are aligned with a corresponding throughhole in the socket, wherein the plurality of internally threadedfasteners are structured to receive the plurality of threaded fastenersthereby securing the pylon to the socket.
 12. The prosthetic device ofclaim 8, wherein the plurality of threaded fasteners comprise a firstinternally threaded fastener, a second internally threaded fastener, athird internally threaded fastener, and a fourth internally threadedfastener
 13. The prosthetic device of claim 12, wherein each of thefirst, second, third, and fourth internally threaded fasteners define acircular opening having a center point, wherein the first, second,third, and fourth internally threaded fasteners are positioned such thatthe four center points define vertices of a square.
 14. The prostheticdevice of claim 8, wherein the connection insert has an overall X-shape.15. The prosthetic device of claim 8, wherein the connection insert hasan overall U-shape.
 16. A prosthetic device comprising: a socketdefining a cavity configured to receive a residual limb of a user, thesocket comprising a base defining a plurality of blind-holes; aplurality of fasteners, each of the plurality of fasteners configured tobe received within a corresponding one of the plurality of blind-holes,wherein the plurality of fasteners each comprise internal threads; apylon comprising a plurality of through-holes, each of the through-holesaligned with a corresponding one of the plurality of blind-holes;wherein the pylon is configured to be directly coupled with the base ofthe socket through a plurality of externally threaded fastenersextending through the through-holes and threadingly coupling with theinternal threads of the plurality of fasteners.
 17. The prostheticdevice of claim 16, wherein the pylon is configured to directly contactan exterior surface of the bottom of the socket when the pylon isdirectly coupled with the base of the socket.
 18. The prosthetic deviceof claim 16, wherein the plurality of fasteners each comprise theinternal threads and external threads, wherein each of the plurality offasteners are threaded into a corresponding one of the plurality ofblind-holes.
 19. The prosthetic device of claim 16, wherein theplurality of fasteners, the plurality of through-holes, the plurality ofblind-holes, and the plurality of externally threaded fasteners comprisefour fasteners, four through-holes, four blind-holes, and fourexternally threaded fasteners.
 20. The prosthetic device of claim 16,wherein the base further comprises a center hole extending through anentire thickness of the base, wherein the plurality of blind holes areradially disposed about the center hole.